This stepped-wedge, cluster-randomized pragmatic trial among six hospitals at University of Pennsylvania Health System will test a behavioral intervention embedded within the electronic health record that nudges hospital clinicians to either provide palliative care (PC) themselves (generalist PC) or consult specialists (specialty PC) for inpatients at high risk of death within 6 months. The trial will evaluate the intervention's effect compared to usual care on the primary outcome of hospital-free days through 6 months, and other patient-centered, clinical, and economic outcomes. The trial also includes an embedded mixed methods study to understand clinician and hospital contextual factors that influence the intervention's uptake.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE
Enrollment
18,884
Clinicians are alerted in the EHR to make an active choice whether to provide generalist palliative care themselves, consult PC specialist, or to defer PC at that time.
Patients meeting eligibility criteria will be enrolled for study data collection but there will be no attempt to influence delivery of care.
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Hospital-free days
Days from enrollment spent alive and not in an acute care hospital through 6 months or death
Time frame: 6 months
Goals of Care (GOC) conversation within a discrete GOC note type
Presence or absence of documented GOC conversation after enrollment detected by natural language programming algorithm or by a discrete GOC note type
Time frame: up to 6 weeks
Pain scores
pain level according to standardized scale across hospitals after enrollment
Time frame: up to 6 weeks
Palliative care consultation note
Presence or absence of signed inpatient palliative care note after enrollment
Time frame: up to 6 weeks
Time to palliative care consult
starts at time of enrollment until receipt of first documented inpatient palliative care consultation note
Time frame: up to 6 weeks
Change in code status found in chart documentation
no change, new limitations on life support (e.g., DNAR, DNI) or discontinued limitations on life support
Time frame: up to 6 weeks
Intensive care unit admission
admitted to any ICU during hospital encounter
Time frame: up to 6 weeks
Hospital length of stay
number of days in hospital staring at enrollment
Time frame: up to 6 weeks
Hospital all-cause mortality
death occurred in the hospital or within 1 day of discharge
Time frame: up to 6 weeks
Hospice enrollment
yes if new hospice enrollment
Time frame: up to 6 weeks
Home or clinic palliative care referral
yes if new home of clinic palliative care order after enrollment
Time frame: up to 6 weeks
Hospital discharge disposition written in discharge order
Discharge to home, other acute facility, skilled nursing facility
Time frame: up to 6 weeks
30-day hospital readmission
readmission within 30 days of discharge
Time frame: 30 days
180-day all cause mortality
180 days after enrollment
Time frame: 180 days
Hospital total costs
continuous hospital costs
Time frame: up to 6 weeks
Future acute care costs
acute care costs over the 6 month follow up period
Time frame: enrollment to 6 months post hospital discharge
Goal-concordant care
yes if treatments received over 6 month follow up align with goals documented in the EHR; no if treatments are misaligned with goals, or goals are unclear or undocumented
Time frame: enrollment to 6 months post hospital discharge
McGill Quality of Life-Revised
14-item survey instrument; score 0-10; continuous
Time frame: 1 month
McGill Quality of Life-Revised
14-item survey instrument; score 0-10; continuous
Time frame: 3 months
McGill Quality of Life-Revised
14-item survey instrument; score 0-10; continuous
Time frame: 6 months
CMS-MACRA PC Quality
(1) felt heard and understood (4-items); (2) received desired help for pain (3-items); continuous
Time frame: 1 month
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